- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01326689
A Comparative Study of KW-2246 (2246-004)
March 6, 2017 updated by: Kyowa Kirin Co., Ltd.
Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)
This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokyo, Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed consent
- Have been treated with opioid analgesic on a fixed-schedule at a stable daily dose
- Receiving at least 1 but not more than 4 doses of rescue medication per day in average and whose pain is controlled
- ECOG PS =< 3
Exclusion Criteria:
- Currently suffered from intolerable opioid-specific adverse reactions due to opioid analgesics
- Severe respiratory dysfunction
- Asthma
- Severe bradyarrhythmia
- Severe hepatic function disorder
- Severe renal function disorder
- Severe psychoneurotic disorder
- Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury or brain tumor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: KW-2246
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Rescue medication at an optimal dose, which is determined by dose titration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity difference
Time Frame: 30 minutes after each dose
|
Pain scores on the visual analog scale
|
30 minutes after each dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
March 30, 2011
First Submitted That Met QC Criteria
March 30, 2011
First Posted (Estimate)
March 31, 2011
Study Record Updates
Last Update Posted (Actual)
March 8, 2017
Last Update Submitted That Met QC Criteria
March 6, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2246-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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